RECRUITING

Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

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Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)antigen presenting cells (APCs)Sipuleucel-T (Sip-T)granulocyte-macrophage colony-stimulating factor (GM-CSF)prostatic acid phosphatase (PAP)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).

Official Title

Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer (OU-SCC-EXCITE)

Quick Facts

Study Start:2023-11-12
Study Completion:2024-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05806814

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Men ≥ 18 years of age
  2. 2. Prostate cancer with history of metastasis
  3. 3. Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer
  4. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  5. 5. Life expectancy of ≥ 6 months
  1. 1. Previously received Sipuleucel-T (Provenge®)
  2. 2. Known malignancies other than prostate cancer likely to require treatment within 6 months following registration
  3. 3. A requirement for systemic immunosuppressive therapy (\>10mg Prednisone daily or equivalent)
  4. 4. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF
  5. 5. Any infection requiring antibiotic therapy within 1 week prior to registration

Contacts and Locations

Study Contact

Lead Onco Nurse
CONTACT
405-271-8777
SCCIITOffice@ouhsc.edu

Principal Investigator

Kelly Stratton, MD
PRINCIPAL_INVESTIGATOR
Investigator

Study Locations (Sites)

Stephenson's Cancer Center
Oklahoma City, Oklahoma, 73114
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Kelly Stratton, MD, PRINCIPAL_INVESTIGATOR, Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-12
Study Completion Date2024-11

Study Record Updates

Study Start Date2023-11-12
Study Completion Date2024-11

Terms related to this study

Keywords Provided by Researchers

  • antigen presenting cells (APCs)
  • Sipuleucel-T (Sip-T)
  • granulocyte-macrophage colony-stimulating factor (GM-CSF)
  • prostatic acid phosphatase (PAP)

Additional Relevant MeSH Terms

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)